PCSK9 court saga drags on for Sanofi, Regeneron and Amgen
- In the ongoing court battle between Amgen and Sanofi SA/Regeneron Pharmaceuticals over patent infringement in the PCSK9 inhibitor class of drugs, the judge in the U.S. Court of Appeals has made the previous legal judgments void and ordered a new trial. This allows Sanofi and Regeneron to continue manufacturing, marketing and selling Praluent in the U.S., despite pushback from Amgen.
- The decision is based on claims that the trial court excluded evidence, improperly instructed the jury and improperly granted an injunction.
- While no timeline has been put forward, the companies all believe it’s unlikely that there will be any new trial proceedings before the end of 2017. Regeneron and Sanofi's shares both rose slightly, and Amgen's dropped a little on the news.
This is proving to be a long story… In 2014, Amgen sued Sanofi and Regeneron, claiming that their PCSK9 inhibitor Praluent (alirocumab) infringed its patents for Repatha (evolocumab). In March 2016, a U.S. District Court jury ruled in favor of Amgen. Settled, far from it.
In January 2017, a federal judge rejected an attempt from Sanofi and Regeneron to reassess the federal jury's decision, and in the same month Amgen was granted a request for a permanent injunction against Sanofi and Regeneron, effectively banning U.S. sales of Praluent. But the saga continues.
In February 2017, Sanofi and Regeneron won a temporary reprieve from the injunction, allowing Praluent to remain on the market throughout the process of appeal against the district court, which Sanofi was hoping would come through in June. But it didn't. And now that the judge has vacated the previous judgments, it effectively all starts all over again.
Needless to say, Regeneron and Sanofi are both upbeat about the decision, especially as Regeneron has already put a full year's worth of revenues of Praluent into its 2017 forecast. Global sales for the drug were just $116 million in 2016.
Ironically, all of this back and forth has been occurring over two drugs that have been colossal disappointments. The PCSK9 class of drugs was a closely-followed battle during its time in the clinic and investors had expected the drugs to be instant blockbuster. Unfortunately, the cholesterol market has been a harder nut to crack than any of the companies expected, and sales of both drugs have been minimal at best.
Instead of being huge blockbusters, the drugs have yet to even crack half a billion dollars with more than a year on the market. These drugs were extremely costly to develop and the ongoing legal battle has only added to their cost of goods, making both Praluent and Repatha major losers for the their developers.
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